Felbatol Approval Marks Year At Carter-Wallace

Carter-Wallace, a US consumer and health care company, received approval from the US Food and Drug Administration for its antiepileptic agent Felbatol (felbamate) in July 1993, and commenced a national launch of the product in October (Marketletters passim). The company says that Felbatol is the first major new antiepileptic agent to be introduced in the USA in over 15 years.

Felbatol's indications include monotherapy and adjunctive therapy for patients with epilepsy aged 14 and over with partial seizures, with and without generalization. It is also indicated for treatment of partial and generalized seizures associated with Lennox Gastaut Syndrome in children as young as two years old.

To date, sales of the product have exceeded expectations with each month posting new highs in market share, according to Carter-Wallace's annual report for the year ended March 31, 1994. During the year the company incurred costs of $14.8 million before tax ($8.88 million net) for prelaunch activities for Felbatol.